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CN111432863B - Manual injection device - Google Patents

Manual injection device Download PDF

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Publication number
CN111432863B
CN111432863B CN201880078995.XA CN201880078995A CN111432863B CN 111432863 B CN111432863 B CN 111432863B CN 201880078995 A CN201880078995 A CN 201880078995A CN 111432863 B CN111432863 B CN 111432863B
Authority
CN
China
Prior art keywords
injection
injection device
reservoir
cannula
needle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
CN201880078995.XA
Other languages
Chinese (zh)
Other versions
CN111432863A (en
Inventor
罗兰·谢里夫-谢克赫
塔巴塔·布尔古瓦
路易斯·帕尔塔·贝尔特朗
弗雷德里克·拉孔布
洛朗斯·拉尚
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edix SA
Original Assignee
Edix SA
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Filing date
Publication date
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Publication of CN111432863A publication Critical patent/CN111432863A/en
Application granted granted Critical
Publication of CN111432863B publication Critical patent/CN111432863B/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A—HUMAN NECESSITIES
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    • A45D34/00—Containers or accessories specially adapted for handling liquid toiletry or cosmetic substances, e.g. perfumes
    • A—HUMAN NECESSITIES
    • A45—HAND OR TRAVELLING ARTICLES
    • A45D—HAIRDRESSING OR SHAVING EQUIPMENT; EQUIPMENT FOR COSMETICS OR COSMETIC TREATMENTS, e.g. FOR MANICURING OR PEDICURING
    • A45D40/00—Casings or accessories specially adapted for storing or handling solid or pasty toiletry or cosmetic substances, e.g. shaving soaps or lipsticks
    • A45D40/02—Casings wherein movement of the lipstick or like solid is a sliding movement
    • A45D40/04—Casings wherein movement of the lipstick or like solid is a sliding movement effected by a screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
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    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
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    • A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
    • A—HUMAN NECESSITIES
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    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Anesthesiology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Cosmetics (AREA)
  • Confectionery (AREA)

Abstract

The invention relates to an injection device comprising a cylindrical body (3) enclosing a reservoir (5) containing a product to be injected, said reservoir being open at one end towards an injection needle (7) and closed at the other end by a plunger (9), the plunger (9) being mounted for translational movement in said reservoir under the control of a plunger rod (11) with a control member (13), the injection device comprising a control unit for controlling the amount of product to be delivered, characterized in that the control unit is arranged on the body (3) in an area outside the area where the body (16) is to be completely held by hand. The invention also relates to a device for filling an injection device.

Description

Manual injection device
Technical Field
The present invention relates to improvements in manual injection devices to improve in particular their simplicity and accuracy of use.
Background
Manual injection devices will be understood hereinafter as injection devices, such as syringes or equivalent means, intended for use in performing medical treatments, such as intradermal, subcutaneous, intramuscular, intravenous, topical, transdermal or by any other known route of administration.
Many treatments are known that require administration of the product by injection. These are mainly therapeutic or prophylactic treatments, but also include other applications, such as certain aesthetic, cosmetic, dermatological, dental or orthopedic treatments. In addition to use in humans, injection finds increasing application in the field of veterinary therapy.
In general, the medical sector is facing a trend towards an increasing demand for injection therapies. Also, in the near future, the need for innovative solutions for performing these injections is expected to increase in order to increase the comfort of the user and to solve new problems with injection of more and more complex products that are not easily administered (especially due to their high viscosity, high concentration), or stability problems before or during injection.
In addition, it is known that more and more treatments are long-term and that many treatments are or can be advantageously performed outside of the hospital or even at the patient's home. It is therefore important to improve the patient's injection experience to ensure compliance with the therapy, especially because medical personnel know that a significant portion of patients cannot follow the prescription completely due to concerns about needle sticks, injection pain, and even lack of a healthy injection site for daily injection of their therapeutic drugs.
Various studies have been conducted to analyze patient expectations in order to identify possible improvements in the field of injection and specific aspects that may benefit as a result of these improvements.
These studies indicate that the basic requirements can be summarized as follows:
Manual injection with greater force and better control of the injection force and speed, even with very viscous or pasty products, so that finer needles can be used compared to the needles required for usual manual injections for syringes or other injection devices,
improving the accuracy and control of manual injection devices, in particular for smaller or more difficult to control injection volumes and speeds than with current manual injection devices (e.g. syringe type devices),
even with longer implantation times and/or with injection mechanisms different from manual syringe type injections, the stability of the injection site and the inserted needle can be better determined,
this can be done using conventional containers and usual manufacturing methods for manual injection devices (of the syringe type, for example).
To meet these basic requirements, various devices have been proposed which attempt to improve the operation of injection devices, reduce needle size, control the rate of administration or control the force of injection, some of which constitute alternative solutions to injectors, such as syringe pumps, auto-injectors, pen injectors, etc.
It is also known that devices utilizing rotary injection mechanisms are widely tried and tested in order to perform or control injection from a reservoir closed by a movable plunger, as described in US2,283,915 patent.
In addition, a rotary injection mechanism using a threaded plunger rod has been proposed in US4,189,065, the rotation of which in a nut integral with the syringe causes the plunger to move longitudinally in the syringe.
It should be noted that for medical and care professionals, injection is performed by translation, whereas for the general population, this action is less common, less natural and more difficult than rotation. Indeed, translational injection is an atypical action that is never performed in daily life. This action requires precise positioning of three fingers. Such translation may give the patient the impression of something being introduced into his/her body by the thumb moving under pressure towards the skin. The action performed without a fixed support causes stability problems which can lead to the movement of the inserted needle and hamper the accuracy of the dose. This action is in turn sensitive to the pressure received, which can be regarded as variable, making it difficult to perform at a constant speed from beginning to end. Finally, in this unstable holding position, it is difficult to pause the injection process in response to perceived pain.
Rotary injection is a usual motion (or posture) performed in daily life and can be performed without using different fingers (even hands) for accurate positioning. This rotation avoids the impression of something being introduced into the body and greatly reduces the pressure on the skin. This action is performed using a stabilizable means and a fixed support of the needle, is insensitive to pressure and naturally occurs at a constant speed. In this stable holding position, suspension (injection) is easily achieved based on perception.
Another limiting factor associated with injection, especially when the injection is performed by a non-professional and involves viscous or pasty products, is the knowledge of when the full dose has been injected. Faced with this uncertainty, there is a tendency to press very hard at the end of the injection, causing pain due to pressure and movement of the needle in the tissue.
For translational injections, the visibility of the plunger at the bottom of the reservoir of the syringe is always difficult even very close to the injection point, whereas for rotational injections, for example injections with the device according to the invention, it is not possible to exert a force under pressure and there may be an accurate and visible rotational stop point which may indicate the end of the injection. Furthermore, the graduations are arranged at a higher level of the device body, which is easier to read than the graduations on the base in contact with the skin.
In the case of translationally operated pressure autoinjectors, these devices exert significant pressure on the skin, which is difficult to accept and tolerate by patients, especially for children and elderly persons, which represents a true stinging or impact sensation.
Disclosure of Invention
The present invention aims to provide a new injection device which retains the useful characteristics of auto-injectors and pen-injectors, but which remains simple, small, lightweight and sturdy as conventional injection devices of the injector type and which can therefore be easily transported.
The new device according to the invention can equally be used for administration other than injection, for example topical administration, administration similar to methodological (or mei-tachy) therapy, or administration in milk (in veterinary medicine).
The invention thus relates to an injection device of the type comprising a cylindrical body containing a reservoir containing a product to be injected, the reservoir being open at one end towards the injection needle and being closed at its other end by a plunger mounted for translational movement in the reservoir under the control of a plunger rod having a control member, the injection device comprising a control unit for controlling the amount of product to be delivered, characterized in that said control unit is arranged in an area of the body outside an area intended to be fully held by hand, preferably in a distal area thereof.
The plunger rod may have a threaded portion onto which the adjustment wheel is to be screwed and the body may comprise two end stops, namely a distal stop and a proximal stop, between which the adjustment wheel is positionable.
The adjustment wheel may have a plurality of graduations on its periphery, which are visible at the proximal end of the body, and the body may comprise at least one index, the cooperation of which with the plurality of graduations will allow the rotation angle of the adjustment wheel and its longitudinal displacement relative to the threaded portion to be determined. The region of the adjustment wheel with the plurality of graduations may protrude laterally from the body in at least one region.
Further, the proximal portion of the body may at least partially cover the adjustment wheel and may include at least one transparent region through which at least one of the plurality of graduations may be seen.
The proximal end portion of the body may form a cylindrical housing, in particular a cylindrical housing open on one of its sides, which is penetrated by a threaded portion of the plunger rod, the adjustment wheel being movable by screwing or unscrewing on the threaded portion in order to pass from the proximal stop to the distal stop, which stops are constituted for example by two end walls of the housing.
Finally, the edge of the adjustment wheel may constitute an index, the cooperation of which with a plurality of graduations on the body will make it possible to determine the rotation angle of said adjustment wheel and thus its longitudinal displacement with respect to the threaded portion.
The reservoir of the device according to the invention may consist of a standard, single-or double-chamber cartridge or syringe, the plunger rod of which may comprise an anti-rotation element, e.g. a longitudinal groove, a flat on its threaded portion in contact with a complementary portion of the body or housing, or an element which frictionally acts on the inner wall of said reservoir, e.g. an O-ring.
In one embodiment, the distal portion of the body of the injection device may comprise an extension element which may terminate in a tapered portion which is to be penetrated by a cannula of the injection needle which extends beyond the distal portion of the extension element by a length equal to the desired insertable length of said cannula.
According to the invention, the plunger rod of the injection device may comprise at least one threaded portion which is to be engaged with a nut integral with the body, and the control member is to be in the form of a bell extending towards the distal end of the body and being able to cover a portion of the body.
The invention also relates to an injection needle comprising a cannula fixed to a base, which base may comprise an axially centred circular plate on the same axis as an adjacent cylindrical boss, which cylindrical boss is hollowed out with a cavity communicating with the passage of the needle, which cavity forms a converging duct from its proximal end portion towards its distal end portion.
In a variant embodiment, the injection needle will comprise a cannula fixed to a cylindrical base formed by a tubular element comprising a tube arranged in an extension of the tube of the cannula and having an inner diameter larger than the inner diameter of the cannula, the outer diameter of the base may be larger than the outer diameter of the cannula.
In one embodiment the circular plate of the base of the needle will rest against the distal face of the single-or double-chamber reservoir, in particular the cartridge, by means of a holding member, in particular a crimping member. In a particularly advantageous manner, the connection between the base and the distal face of the reservoir will be made in an unsealed manner, so that when the needle is implanted in a vein, the blood pressure allows air to escape and the blood at the distal end of the reservoir rises.
The injection device may comprise a cylindrical body enclosing a reservoir, in particular consisting of a single-or double-chamber cartridge or syringe, containing the product to be injected, which reservoir is open towards the injection needle at one end and closed at the other end by a plunger mounted for translatable movement in said reservoir under the control of a plunger rod provided with a control member, said body comprising means for holding the reservoir, which means may be movable, and the length of the body being such as to allow exceeding the length of the cannula, which length is equal to the length of the desired insertion. The plunger rod may comprise at least one threaded portion to be engaged with a nut integral with the body, the control member being bell-shaped extending towards the distal end of the body and being adapted to cover a portion of the body.
The invention also relates to a device for filling a reservoir, in particular a single-or double-chamber cartridge or syringe, with a product to be injected, the device comprising a container for storing the product to be injected, the container comprising a filling nozzle which can be inserted into the neck of the reservoir. Sealing means are provided between the neck and the nozzle, which sealing means may comprise an O-ring placed in a circular groove between the neck of the reservoir and the nozzle.
The invention also relates to a method for filling a single-or double-chamber reservoir, in particular a cartridge or a syringe, with a therapeutic product, the reservoir being provided with a plunger and ending at its distal end in a neck, said method comprising the steps of:
disposing the plunger at the distal end of the reservoir,
introducing a nozzle of a storage container containing the therapeutic product to be injected into the neck of the reservoir,
-transferring the product to be injected from the storage container into the reservoir, the plunger of the latter being pushed back by said product to be injected.
The invention also relates to a single-or double-chamber reservoir, in particular a cartridge or a syringe, comprising a product to be injected, a reservoir neck and a plunger, wherein the product to be injected extends into the reservoir between the neck and the plunger of the reservoir, without an air gap (or air space) between the neck and the plunger.
The invention also relates to a filling device for filling a single-or double-chamber reservoir, in particular a cartridge or a syringe, with a plunger and having an injection needle at its distal end, comprising a cylindrical receiving housing, which is penetrated at each of its ends by a longitudinal cylindrical container (or receiver), i.e. a container formed at its proximal end portion capable of holding the reservoir, and a container formed at its distal end portion capable of holding a filling container, which is closed by a septum, the filling container comprising means for pushing the therapeutic product, stop means being provided for fixing the reservoir in a position in the housing such that its needle has penetrated the septum and penetrated into the filling container. Preferably, the receiving housing will be provided with means to enable the position of the plunger of the reservoir to be seen when the reservoir is in place in its container, and means to enable the displacement of the plunger to be measured.
The injection device according to the invention may comprise a plunger which is moved by a plunger rod under the influence of a control head, and an injection needle at its distal end, and the proximal end of the plunger rod may comprise means adapted to be successively detachably engaged with the pressure plunger control head on the one hand and the rotary plunger control head on the other hand. Preferably, the plunger rod will have a circular cross section and the injection device will comprise a nut which can be fixed on the proximal part of the reservoir, the diameter of the threaded bore of which is larger than the diameter of the plunger rod and smaller than the inner diameter of the reservoir.
In such an injection device the pressure plunger control head consists of a cylindrical element with a diameter smaller than the diameter of the threaded bore of the nut so that it can be accommodated in the reservoir, which cylindrical element can be connected to the proximal end of the plunger rod.
In this same injection device, the rotary plunger control head comprises a screw which is capable of being screwed into a threaded bore of the nut such that it rests on the proximal end portion of the plunger rod and is capable of pushing it towards the distal end of the reservoir when the screw is screwed. The screw will preferably be integral with the bottom of the cap.
The invention also relates to a device for filling and packaging a set of single-or double-chamber reservoirs, in particular cartridges or syringes, comprising a receiving tub provided with means capable of holding rows of reservoirs in a vertical position, and a lid capable of closing the receiving tub, comprising:
Alignment means capable of maintaining the cap in the same lateral position with respect to the reservoir,
elastic means able to push the lid into the open position,
means provided on the inner surface of the lid of the receiving tub for holding a plunger receivable in the reservoir above each reservoir.
The invention also relates to a method for filling and packaging a set of single-or double-chamber containers, in particular cartridges or syringes, with a product in a device comprising a receiving tub provided with means capable of holding a plurality of rows of reservoirs in a vertical position and a lid capable of closing the receiving tub, the lower surface of the lid comprising a plunger aligned with each reservoir, said method comprising the steps of:
filling a reservoir contained in the receiving tub with a product,
-possibly subjecting the product to a treatment,
-creating a vacuum in the receiving tub,
closing the lid, pushing the plunger into the reservoir,
breaking the vacuum to hold the plunger in the reservoir,
-opening the lid.
Drawings
Embodiments of the invention will now be described, by way of non-limiting example, with reference to the accompanying drawings, in which:
figure 1 is an elevation view in axial and longitudinal section of a first embodiment of an injection device according to the invention,
Figure 1a is an enlarged view of the distal end of the injection device shown in figure 1,
figure 2 is a top view of the injection device shown in figure 1,
figure 3 is a cross-section of the injection device shown in figure 1 along its line AA,
figure 4 is a left perspective view of the injection device shown in figure 1,
figure 5 is a perspective view of the injection device shown in figures 1 to 4 fully held by hand,
figure 6 is an elevation view in axial and longitudinal section of a variant embodiment of the injection device shown in figures 1 to 5,
figure 6a is a schematic view of an indexing device for use on the injection device shown in figures 6 and 7,
figure 7 is a perspective view of the injection device shown in figure 6,
figure 8 is an axial and longitudinal cross-sectional view of a second embodiment of an injection device according to the invention,
figure 8a is an enlarged longitudinal cross-sectional view of an embodiment of an injection needle according to the invention,
figure 8b is an enlarged partial axial and longitudinal cross-sectional view of the needle shown in figure 8a,
figure 9 is a top view of the injection device shown in figure 8,
figure 9a is a perspective view of the injection device shown in figures 8 and 9 fully held by hand,
figure 10 is an axial and longitudinal cross-sectional view of a variant embodiment of an injection device according to the invention,
figure 10a is an enlarged view of an axial and longitudinal section of a needle suitable for use in the injection device shown in figure 10,
Figures 11 and 12 are axial and longitudinal sectional views of an injection device for injection control by rotation before and after injection respectively,
figure 11a is a partial axial and longitudinal cross-sectional view of the distal portion of the variation of the injection device shown in figure 11,
figure 13 is a partial axial cross-sectional view of a device for filling a single or dual chamber cartridge or syringe,
figures 14 and 15 are axial and longitudinal sectional and top views respectively of another device for filling a single or dual chamber cartridge or syringe,
fig. 16a to 16c are partial views of the proximal end of a syringe, which is capable of two possible modes of injection, namely by pressure and by rotation,
figure 17 is a cross-sectional view of a device for packaging a series of single or dual chamber cartridges or syringes,
figure 18 is a perspective view of an embodiment of the present invention,
figure 19 is an axial and longitudinal cross-sectional view of the embodiment shown in figure 18,
figure 20 is an axial and longitudinal cross-sectional view of an embodiment of an injection device according to the invention in a rest or pre-injection position,
figure 20a is an enlarged view of region a of the injection device as shown in figure 20,
figure 21 is a perspective view of the injection device shown in figure 20,
figure 22 is an axial and longitudinal cross-sectional view of the injection device of figure 20 shown during an injection process,
Figure 22a is an enlarged view of region B of the injection device as shown in figure 22,
figure 23 is an axial and longitudinal sectional view showing the injection device of figures 20 and 22 after injection is completed,
fig. 23a is an enlarged view of region C of the injection device shown in fig. 23.
Detailed Description
Fig. 1 to 5 show a first embodiment of an injection device according to the invention, which is mainly intended for intradermal or subcutaneous injection.
This injection device 1, which is of a similar construction to a syringe, comprises a tubular body 3, inside which a reservoir 5 containing the product to be injected is arranged, the tubular body 3 ending in an injection needle 7, the injection needle 7 being provided with a cannula 7a. In a known manner, the plunger 9 is mounted slidable within the reservoir 5 under the action of a plunger rod 11, the outer end of which is herein referred to as the proximal end, comprising an injection control head 13.
In order to ensure good contact of the plunger 9 with the reservoir 5 and to obtain good dosing accuracy, and to resist the pressure exerted, for example, during injection of viscous or pasty products, according to the invention solid plungers of conventional type, such as those used in dental cartridge syringes or in some pen syringes, are advantageously used.
The plunger rod 11 has a threaded portion 11a on which a nut is screwed, the nut forming an adjustment wheel 15 of thickness e, which is able to move longitudinally between two stops (distal stop 17a and proximal stop 17b, respectively) of the tubular body 3, spaced apart by a distance d which depends on the maximum amount of product desired to be injected, as described below.
In an alternative embodiment of the invention, the plunger rod 11 is provided on its outer circumference with a friction element consisting of an O-ring 22 arranged in a groove of the plunger rod, which friction element abuts against the wall of the reservoir 5 in order to create friction forces such that rotation of the plunger rod 11 during injection or when the device is not used or when the adjustment wheel 15 is actuated can be avoided.
The O-ring 22 can provide this friction without creating a sealing barrier, for example by means of an opening formed in the groove, not shown in the figures. In this way, the plunger rod 11 may be inserted into the reservoir 5 until it contacts the plunger 9 without trapping air between its distal end and the plunger.
In another embodiment of the invention, as shown in fig. 18 and 19, the plunger rod 11 comprises a longitudinal flat 12, the function of which is to prevent rotation of the plunger rod during longitudinal displacement during injection. For this purpose, at least one of the two stops 17a, 17b comprises a planar portion 12a, the flat portion 12 of the plunger rod 11 being in contact with this planar portion 12 a. In this way, the plunger rod 11 cannot rotate and can only move translationally during injection.
As shown in fig. 3 and 4, in this exemplary embodiment, the adjustment wheel 15 is in the form of a disc that includes a recess 19 on its outer periphery to improve the grip of the wheel 15 by the user. The proximal surface of the adjustment wheel 15 has graduations 18 on its periphery, the graduations 18 being distributed in particular in a uniform manner around its periphery and conforming to an index 20 formed on the proximal stop 17b of the body 3. In a variation of this exemplary embodiment, the proximal stop 17b may also be a transparent material so that the user can read the scale 18 through it.
Under these conditions, after the user has made a "preparation" (i.e. an operation prior to injection) to expel the air contained in the reservoir 5 of the injection device, the wheel 15 is brought into contact with the distal stop 17 a. The user then rotates the wheel to position it on the selected scale so that it can be moved a distance backwards to eject the desired amount of product, as shown in figure 1.
For example, if the pitch of the threaded portion 11a is equal to p and the wheel 15 has N graduations and the diameter of the reservoir 5 is D mm, it will be appreciated that the rotation of the wheel by N zones corresponds to an injection volume equal to:
(p x n)/N xπ.D2/4
thus, for a pitch p=0.2 mm, the number of graduations n=20 and the reservoir diameter d=8 mm, each graduation will correspond to 0.5mm 3 Is used for the injection volume of (a).
As shown in fig. 18 and 19, an injection device according to the invention may be provided with a reset ring 16. The ring will allow the user to select different doses of the injectable product for each administration if desired. For this purpose, the reset ring 16 is rotatably mounted on the body 3 and has an index mark 21, which index mark 21 serves as a starting point for dose selection.
In fact, once the first dose is selected and administered, the user needs a reference point to reset in order to select the second dose, the third dose, etc. Since each dose can be varied, the zero position of the adjustment wheel 15 is found again at a different position after each administration, which is indicated by the index 15 a. According to the invention, in order to set a new dose, the user must place index 21 of reset ring 16 opposite index 15a of the adjustment wheel and then rotate the adjustment wheel by an angle with respect to index 21, corresponding to the new desired dose.
First of all, the present invention is particularly advantageous in that it allows the user to pre-select the amount of product to be injected into the patient, so that he/she does not have to worry about controlling the amount of product infused during injection.
In addition, it has been found that small amounts of product can be injected particularly precisely, which prior art devices are not injectable. It should also be noted that injections of these micro volumes, e.g. less than 0.05mL, are not painful for the patient, which e.g. makes it possible to repeat the injection.
These micro-doses (a few microliters) are particularly useful in many therapeutic fields, such as pediatric, veterinary (small animals), dermatological (intradermal injection of products against acne, warts and other skin diseases), vaccine or certain botulinum toxins for use in applications or cosmetics of the "Mesotherapy" type. In the case of cosmetic applications, the device may be provided with one or more very thin needles, for example 0.1mm in diameter, 0.2mm in length, or may even be provided without needles, but with a dispensing tip. Furthermore, the present invention makes it possible to dispense with the present injection device being used as in a conventional type syringe which is held between two fingers and the user's thumb, i.e. in a lateral-outward finger grip, but for example in a finger grip, i.e. with the entire hand placed on the body 3, the user's thumb being located on the head 13 of the plunger rod 11, as shown in fig. 5.
This gripping by hand allows in particular easy self-management for controlled volumes of product. This hand-held approach also allows for easy multi-dose designs so that these controlled volumes can be repeatedly infused, for example for use in a methodological or filled product application, with varying injection sites.
The applicant has also found that this manual grip enables an easy and comfortable application of a greater injection force on the plunger 9 than can be applied by conventional injection devices, with a high dose accuracy, and without the user having to undergo the usual disturbing movements of conventional injections. Thus, such hand gripping also allows the use of a needle with a much finer cannula than previously used to inject the same product.
In fact, the invention makes it possible to separate the two functions that have been confused so far, namely the gripping function on the one hand and the injection function on the other hand. Thus, according to the present invention, the grip of the injection device is fixed throughout the injection process, as it is "done by the whole hand", i.e. by four fingers of the user's hand, except the thumb, and the injection is performed by the thumb of the user. In contrast, in conventional injection devices, the grip ensured by the thumb-assisted index and middle fingers varies throughout the injection process, as the moving thumb constitutes one of the elements holding the injection device in place.
However, the applicant has found that this separation of functions makes it easier to apply a greater injection force, so that more viscous products, such as biopolymer fillers, e.g. hyaluronic acid, collagen or elastin, even polylactic acid (PLA), can be injected, or to reduce the size of the needle used to inject a given product, on the other hand without exerting excessive pressure on the patient's skin surface during the injection.
From the above, it will be appreciated that this hand grip is possible because the amount of injected product is controlled outside the area of the injection device that is fully gripped by the hand (i.e. in this example in the distal end area of the injection device).
In a variant embodiment of the invention, the effectiveness of the hand-held full grip allowed by the invention is further improved by providing the distal portion of the injection device with an extension element 28, the extension element 28 allowing adjustment of the injection depth, as shown in fig. 1, 1a and 2, the extension element being adapted to be secured to the distal end of the body 3, for example by screwing or clamping.
The extension element 28 terminates forward in a conical portion 30 which is penetrated by the cannula 7a of the needle 7 and is of the type known in the art for pen injectors. The extension element 28 has a reduced length and diameter, which is much smaller than the diameter of the body 3, allowing on the one hand a user to precisely align the injection site and on the other hand enabling the user to control the required insertion depth of the cannula of the needle. Thus, during injection, the user will bring the end of the conical portion 30 into contact with the patient's skin, so that the insertion length of the cannula 7a of the needle 7 is equal to its distance beyond said conical portion 30 l。
To adjust the insertion length, the length of the tapered portion 30 may be variedfOr the length of the cannula of the needle 7l。
Thus, according to the present invention, a user may have a series of extension elements 28 with the length of their tapered portions 30fWill be different, which will enable him/her to adjust the insertion length of the cannula 7a according to the desired injection depthl。
For example, in cosmetic applications, the length of the extension element may be adjusted so that the length of insertion is so small that the cannula of the needle itself cannot penetrate the dermis, and the skin surface or stratum corneum is penetrated only by the beveled tip by a thickness of only 0.10 mm. In this very special case, for example during the treatment of Mesoxhlet therapy, the penetration of the cosmetic product into the skin will be improved due to these micro-lesions created by the cannula tip of the needle, but the product is not injected, but deposited on the surface of these micro-lesions.
In another embodiment of the invention, the needle may be secured directly in the extension member 28 to form a single piece, which would allow the user to have different cannula lengthslHe/she will choose the cannula length according to the injection depth he/she wants to reach.
It should be noted that this extension element 28 thus performs three functions, namely the function of adjusting the insertion length of the cannula of the needle in the patient, the function of stabilizing the device during the injection operation, because the distal base of its tapered portion 30 remains in contact with the patient's body, and the function of precise alignment of the injection site, which allows to position the needle tip precisely at the desired position. In fact, the device is intended for use with very fine needles (29G or higher), which are difficult to target at the injection site because the exposed needle is too thin to see.
The injection device according to the invention thus makes it possible to perform an intradermal injection precisely, for example in wrinkles, at a determined and reproducible maximum depth. The length may also be suitable for other precise targets or injection sites, for example for vaccines or for intradermal injection of peptides and proteins, products for the treatment of diabetes, such as insulin or GLP-1 analogues, especially pre-meal insulin, which have a greater rate of action when injected intradermally.
Such an injection device according to the invention is particularly suitable in the case of pediatric administration, wherein the dose of the therapeutic product is particularly low, resulting in a reduction in volume. For example, it is possible to use commercial products and, without changing the concentration, it is possible to simply apply small doses of the same product with high precision thanks to the device according to the invention. This allows to keep the same product already registered, without going through all the steps of the re-planning and some clinical phases of research that are lengthy and expensive, the treatment field being modified by means of this new specific device.
In a particular embodiment of the invention, the conical portion 30, which completely covers the needle 7 and can be provided with different shapes and dimensions, is used to constitute a device for topical application of products particularly useful in the ophthalmic field, since it can provide better stability during administration without touching the surface of the eye.
In a variant of the invention and as shown in fig. 1, the reservoir may consist of a cartridge of a standard type, for example a dental cartridge or a dual chamber cartridge for temporary reconstitution, the standard volume of which may vary between 1ml and 3ml, which is manufactured, filled and closed by a diaphragm-type closure element sealed by a ring, with the advantage that it can be implemented on existing production lines at reasonable cost.
The present invention makes it possible to provide an injection device of the multi-dose type, that is to say that it can deliver a number of adjustable volumes of injection from a reservoir or cartridge (even a double chamber) by means of a continuous positioning of the adjustment wheel 15, without having to refill the product between each treatment. Such multi-dose devices are particularly suitable for performing very small volumes of injections, such as intradermal injections, under precise conditions. In addition, it has been found that due to the small size of the needle and the injection volume, e.g. less than 0.05mL, painless injection is possible, allowing multiple injection sites in the same administration area. For example, a device of this type according to the invention is particularly suitable for the administration of a product directed against hyperhidrosis, such as botulinum toxin, in the palm or sole of the foot, wherein repeated injections of small doses of the product in the dermis of the patient are required. If such a toxin is targeted to an intradermal compartment, it can also be used to intradermally inject a therapeutic product into the skull skin of a patient suffering from alopecia that will have improved therapeutic efficacy over conventional injections.
Such an injection device is particularly suitable for providing a disposable device, in particular when its reservoir is constituted by a single-or double-chamber cartridge of standard type, which is then manufactured in sealed form in the body 3.
The injection device according to the invention may be preloaded with the product to be injected. It may also be empty, e.g. the plunger 9 is in contact with the cartridge neck, and may be loaded at the time of use, e.g. by a filling device for filling a syringe as described below, which corresponds to another embodiment of the invention. Thus, it may be used with botulinum toxin pre-reconstituted from its original form. The contents of the container are then transferred to the device, for example by a syringe.
Such a device may also be used with a dual chamber cartridge containing a lyophilized product and its reconstitution medium (reconstitution medium) wherein an intermediate plunger is brought to a bypass area for reconstitution directly in the device according to the invention. In this embodiment, the plunger rod 11 will include a smooth distal portion for reconstitution followed by a coiled proximal portion for administration as previously described. To avoid possible rotation, the plunger rod may also include flats to guide reconstitution.
The locking mechanism may then be provided to a smooth portion of the rod at a position on the lateral bypass area corresponding to the first plunger (distal) position, for example by a key system. The user must then remove the locking system to complete translation of the second plunger (proximal end) until contact is made with the first plunger to enable administration of the reconstituted (reconstituted) product. The locking system must be removed to force the user to stop the plunger travel, thus allowing time for proper fluid replenishment once the two products are in contact. In a further variant, the locking mechanism may also consist of a stop (or stopper) to be passed over when the screw is equipped with a flat part: the first stop initiates plunger travel and the second stop causes the distal plunger to pass through the bypass region prior to administration of the reconstituted product (as described above).
Finally, the device may comprise a system preventing the selection of a larger dose than the remaining dose in the reservoir, and the screw head may be clamped under the housing and in contact with the crown when the cartridge is empty. The crown cannot be rotated to select a dose and the device is locked when empty. It is also possible to precisely prevent the crown from rotating in the form of a pin or a stop placed on the housing, which will prevent the regulating wheel 15 from rotating beyond a certain length of the plunger corresponding to the maximum dose of product that can be administered contained in the reservoir. The pin may be moved to the end of the groove on the upper surface of the crown and then the maximum is fixed. The pin is then released only when the crown drops again after the selected dose has been administered.
Fig. 6 and 7 show a variant embodiment of the invention which is particularly suitable for injection or multiple injections of large-dose products.
In this device, the proximal end portion of the body 3 forms, for example, a cylindrical housing 32 open on one of its sides, which is penetrated by the threaded portion 11a of the plunger rod 11. In this variant, the adjustment wheel 15' has the form of a disc and is movable, as shown in the previous example in fig. 1 to 5, by screwing or unscrewing on the threaded portion 11a to reach the distal stop 17a from the proximal stop 17b, respectively formed by the two end walls of the housing 32.
The index here is constituted by the edge 20 'of the adjustment wheel 15', the graduation 18 being provided on the body of the housing 32.
In addition, the distal portion is provided with an extension element 28', which extension element 28' is constituted by a cylindrical ring snap-fitted onto the body 3 and has a length g such that it allows the cannula 7a of the needle 7 to protrude by a length l equal to the required amount of insertion.
It will be appreciated that by placing the wheel 15' from right to left in the figures at positions 1, 2 and 3, as schematically shown in figure 6a, an injection of volume V1 can be made at position 1, an injection of volumes V3-V1 at position 2 and an injection of volumes V6-V3 at position 3, respectively.
Such injection devices thus allow for injection of a pre-set accurate dose to a specific part of the patient's body, facilitating intradermal or subcutaneous injection, which can therefore be performed by an inexperienced user or by a person with dexterity, or by the patient himself.
Fig. 8 to 9 show a further embodiment of an injection device according to the invention, basically having a tubular body 3, inside which a reservoir 5 is accommodated, a plunger 9 of the aforementioned type being mounted in the reservoir 5 so as to be longitudinally movable under the influence of a plunger rod 11a constituted by a screw. The plunger rod 11a is fixed at its distal end to the plunger 9 and extends through a nut 14 integral with the body 3 to terminate at its proximal end in a bell-shaped head 13'. Which covers the plunger rod 11a and a part of the body 3.
Under these conditions, it will be appreciated that rotation of the head 13' controls the longitudinal displacement of the plunger 9 in the reservoir 5 and the expulsion of a given volume of therapeutic product through the injection needle 7.
The injection volume is controlled by graduations 18' provided on the body 3 and the index may be formed by the distal edge 13' a of the head 13', as shown in fig. 9. This embodiment is particularly advantageous in that it allows reading (graduation values) on the rear or proximal portion of the body 3, the front or distal portion of the body 3 being held entirely by hand in the region 16 (hereinafter referred to as "distal holding region").
Of course, any other measuring system may be used according to the invention, as long as it is outside the area where the user grips the body 3 with the whole hand, i.e. outside the distal grip area 16. Such a measuring system may also consist of a longitudinal index arranged on the body 3 and the head 13', respectively, which may coincide with each given number of turns of the screw 11'.
In this exemplary embodiment, and as shown in fig. 8, 8a and 8b, the injection needle 7 comprises a base 36, the cannula 7a of which is attached to the base 36, for example by gluing, press fitting, welding, for example electron beam welding. The base 36 is formed on the one hand by a flange 36a having the shape and size of a septum, which generally encloses a reservoir, in particular a reservoir constituted by a standard cartridge. The proximal face of the flange extends inwardly from the neck 5a of the cartridge through boss 36 b. As shown in fig. 8, 8a and 8b, the boss has a frustoconical cavity 36c converging proximally to distally.
The boss 36b has a diameter such that it can be received in the neck 5a of the cartridge and the base 36a is attached to the neck 5a of the cartridge by crimping means such as a ring 39, as is the septum on a conventional cartridge.
It can be seen that such an embodiment provides two functions not found in the prior art.
First, by allowing the proximal end of the cannula 7a to be almost flush with the outlet neck 5a of the cartridge 5, the unnecessary length of the cannula 7a may be reduced as much as possible.
Second, the converging design formed by cavity 36c facilitates the flow of the product to be injected.
Thus, these two new functions created by such an embodiment cooperate to reduce the importance of the pressure drop exerted on the injected product during the injection operation, which makes it possible to reduce the force necessary to inject the product for a given inner diameter of the cannula 7a or to reduce the inner diameter of the cannula 7a for a given injection force.
Of course, according to the invention, the same function may be achieved with a reservoir other than a standard cartridge, such as a syringe or other conventional container made of glass, plastic or any other material, and furthermore, whatever its respective volume.
While using conventional containers, the device can inject a much more viscous or even pasty product than many commercial devices. Injection of such viscous or semisolid products allows for a reduction in the dosage of certain patients requiring high therapeutic doses, for example in oncology, monoclonal antibodies. Such high viscosity makes it possible to increase the concentration of the active ingredient, for example, beyond its solubility in subcutaneous solutions in which the molecules of the active ingredient may have a specific arrangement, thus contributing to its concentration, stability and injectability, for example by reducing the shear stress exerted during administration. Thus, the device facilitates special injections, such as intra-articular or intravitreal injections, or even injections of biological glue or wrinkling fillers, with greater strength and accuracy by using finer needles, even for more viscous, longer-acting products.
The device according to the invention makes it possible to control the rate of administration according to the patient's sensation (pain) and to pause during administration. For injection, due to the high stability at the injection site, it is possible to wait a little bit before continuing administration without causing parasitic movements of the inserted needle, which is currently difficult with current translationally operated injection devices.
In the operating mode shown in fig. 8, the body 3 is provided with a cap 34 fitted on the body and able to cover the needle 7. The cap has an inner insert 35, in particular made of rubber or butyl rubber, which in the closed position rests on the bevel of the cannula 7a of the needle 7 to seal the cartridge 5.
Of course, cap 34 may not include any system that contacts cannula 7a of needle 7, for example, if the product to be injected has a viscosity that does not allow it to flow through the cannula without pressure. This makes it possible to obtain a needle pre-assembled on the reservoir, which needle does not undergo any contact before insertion.
The cap, thanks to its ergonomic design, will allow the device according to the invention to be covered with only one hand and laid sideways on a table, avoiding the risk of needle stick injuries.
Also, it cannot be activated by children.
In another embodiment of the invention, the reservoir may be a standard pre-filled syringe, e.g. of the Hypak type, 0.5mL, with a diameter smaller than that of a standard cartridge, comprising a luer distal end closed by a standard butyl stopper, and a retaining fin at its proximal end.
Although the 0.5ml syringe has a smaller inside diameter than a standard cartridge and is more suitable for administration of viscous products, the 0.5ml syringe has the disadvantage of not being luer-locked (luer-lock) at its distal end or any particular gripping means when injecting viscous medicaments.
Since the device according to the invention makes it possible to obtain a conventional but more durable luer lock fitting without any risk of the needle rotating or breaking, the design is more suitable for viscous products.
The syringe is inserted into the body 3 which is in contact with the skin during injection. In this particular embodiment, the distal portion of the body 3 terminates in a male luer lock tip without a luer taper; a luer taper of a 0.5mL syringe and a special butyl rubber stopper extend from the distal end. Glass wings at the proximal end of the syringe can be moved in two recesses formed on both sides of the proximal end of the body 3 up to a distance l, wherein the wings form a distal stop in the recesses in a lower position before use. At this point, the luer taper of the needle is exposed through the distal portion of the body 3 and the butyl stopper may be removed and replaced with a standard needle. The rotating needle is attached (fixed) into the luer lock, translating the syringe through the notch within the body 3 to a higher locking position where the wings form a proximal stop. The movement of the wings within the body 3 serves as a visual inspection to ensure needle assembly. In this new configuration, the frangible wings of the glass syringe will no longer withstand the full pressure during injection, which is distributed over the distal portion of the glass syringe, from the outer surface of the luer cone through the plastic base and luer lock portion of the plastic body at the distal level, to the proximal end of the body 3. This new stronger assembly around the luer lock end can apply greater injection forces. This new luer lock assembly may also be used in conventional syringe versions, with the body terminating in its proximal portion by a finger rest and a standard plunger rod.
In another embodiment of the device according to the invention, which may have the same function as previously described, around a 0.5mL syringe, but in this particular case is preferably connected to the prefilled syringe by lateral clamping; in this way, a specific component can be added which can be clipped onto the taper of the needle base to control and ensure its correct insertion and retention on the luer end of the syringe. This clamped portion of the body 3 may comprise other elements according to the invention having the functions already described, such as a rest portion resting on the skin at its distal end or an adhesive protection system that may be present.
This particular part of the device is clamped laterally on the base, ensuring that there is sufficient connection between the syringe and the needle to enable injection of the viscous product. In some applications, the device according to the invention may also be extended at its proximal end by a finger rest associated with the plunger rod to allow it to be used like a conventional syringe.
Still surrounding about 0.5mL of prefilled syringe reservoir, a fixed needle version may be provided as compared to the needles envisaged for the syringe. In this particular case, a needle with a metal base may be inserted through the proximal opening of the reservoir. The base has a shape adapted to the inside diameter of the reservoir so as to reach an abutment position inside the syringe on the luer end side. The cannula of the needle then protrudes through the opening of the end; the cannula may be plugged with a suitable butyl rubber plug to protect the product to be administered until injection. The main advantage of this arrangement is to provide a version with the required diameter of the needle installed without contact with any plastic.
Also, this solution can reduce the dead volume and the injection force required for administering the same product compared to the previously described version with a standard needle connected by its plastic cone. It is also possible to incorporate the intravenous testing device by providing an opening or air escape point between the cannula and the product to be injected that is of a diameter that is much smaller than the diameter of the viscous product, but large enough to allow air to pass and blood to rise.
This fixed needle solution is applicable both to the screw system according to the invention described above and to standard syringe arrangements with conventional plunger rods.
Fig. 10 shows an injection device, the body 3 of which accommodates a standard cartridge 5, the septum 6 being intended to be pierced by a needle 7 when the cartridge 5 is inserted into the body 3. In this example, as shown in figure 10a, the needle 7 is made up of two parts, namely an outer front part 7a of conventional type, the inner diameter of whichd1Depending on the product to be injected and the operation to be performed, and the inner rear portion 37, its inner diameterd2Larger. The two parts of the needle 7, the front part 7a and the rear part 37, are joined together, for example by gluing or welding. As shown in fig. 10 and 10a, the front portion 7a of the needle passes through the distal wall of the body 3 in such a way that its rear portion 37 of greater diameter is in contact with the inner surface of said distal wall 3. The free end of the rear portion 37 ends with a bevel to improve its ability to perforate the membrane 6 when the rear portion is placed in the body 3.
Length of the larger diameter rear portion 37mShould be kept as short as possible, i.e. slightly thicker than the membrane of the cartridge to be accommodated by the body 3, so that it passes just through the membrane when the cartridge is put in place.
Thus, it will be appreciated that the larger diameter rear portion 37 performs a variety of functions.
First, because the inner portion 37 forms a shoulder, it provides better retention of the needle 7 relative to the distal portion of the body 3.
Second, due to the insideDiameter of the section piped2Diameter of the duct greater than the front portion 7ad1The pressure drop suffered by the injected product during injection will therefore be less than according to the prior art (when the rear portion 37 has the same diameter as the outside).
Finally, by having this rear portion 37 have a length that just passes through the membrane 6, the pressure drop to which the product is subjected during injection can be further reduced, thus reducing the injection force required. As previously mentioned, this makes it possible to reduce the inner diameter of the needle or to increase the length of the needle, or to inject a less fluid product through a smaller diameter needle than is currently used.
Although the injection device according to the invention has been described above in connection with an example (illustration), in which the reservoir containing the product to be injected is constituted by a cartridge, it is of course also possible to implement it by a reservoir constituted by a standard or non-standard syringe.
Fig. 11, 11a and 12 show an injection device 1 comprising a tubular body 3, a standard syringe 4 being inserted into the tubular body 3, the standard syringe ending in a fixed needle, the cannula 7a of which is protected by a sealing cap 34' made in particular of butyl rubber. The proximal end 47 of the syringe is held in the housing 3 by a nut 49, the nut 49 itself being fixed to the proximal end of the body 3. The nut 49 is threaded by a threaded rod 51, the distal end of which is fixed to the plunger 9 of the syringe 4.
The other end of the threaded rod 51 is an integral part of the bottom of the bell 53, which is dimensioned so that in the position in which the plunger is removed (fig. 11), it slightly covers the body 3. Under these conditions, the injection can be performed by simply rotating the cap 53 with respect to the body 3.
The length of the body is such that its distal end reaches the insertable end of the cannula 7a of the needle and exposes a given length of the cannulalAs shown in fig. 11 and 12.
Furthermore, according to the present invention, it will be appreciated that by adjusting the length of the body 3, for a given syringe equipped with a needle, the cannula 7a of which has a given length, the length of the insertable portion thereof can be adjustedl’As shown in fig. 11 a.
The injection device of the invention thus makes it possible on the one hand to control the insertable length of the cannula 7a and on the other hand to ensure a stable positioning on the skin of the patient during the injection phase, in particular due to the supporting surface of the body 3 on the patient and the grip of the user.
The invention also relates to a filling method and device for an injection system.
In a first embodiment, the means (means) for ensuring the filling or packaging of the injection system 1 or its reservoir 5 starting from the neck 5a of the reservoir 5 have been shown in fig. 13, i.e. contrary to the filling direction commonly used according to the prior art. This filling method is particularly advantageous when the product to be filled into the reservoir 5 has a high viscosity.
The filling device comprises a storage container 40 with a filling head 41, which filling head 41 comprises a connecting nozzle 42 of such a diameter that it can be inserted into the neck 5a and pierced by a supply conduit 44. The tightness between the nozzle 42 and the neck 5a of the injection device can be ensured by a seal, for example an O-ring 45, which is mounted in a circular groove of said nozzle 42.
As shown in fig. 13, prior to filling, the plunger 9 of the injection device 1 contacts (abuts) the inlet of the neck 5 a. If the therapeutic product is injected through the feed line 44 during the filling phase, the plunger 9 is pushed in, thereby filling the desired product dose, while avoiding the drawback of leaving a large amount of air between the plunger and the therapeutic product.
In a second embodiment, fig. 14 and 15 show a filling device 2 of a standard syringe 4, which allows filling the syringe from its distal end, i.e. through the cannula 7a of its needle.
The filling device consists of a cylindrical receiving housing 3a, each end of which cylindrical receiving housing 3a is pierced by a longitudinal cylindrical container, namely a container 60 formed in the proximal portion of the receiving housing capable of containing a syringe 4 and a container 62 formed in the distal portion capable of containing a filling reservoir 64, which is closed in a conventional manner by a septum 6 of the same type as shown in fig. 10.
The filling reservoir 64 is held in place in the container 62 by a nut 66 which is screwed into the housing 3a and threaded therethrough, a threaded rod 68 being screwed into the thread, the distal end of the threaded rod being connected to a plunger 70.
The other end of the threaded rod 68 is an integral part of the bottom of the bell 72, which is dimensioned so that in the retracted position of the plunger 70 it slightly covers the housing 3a.
The distal portion of the container 60 containing the syringe 4 terminates in a boss 74, the boss 74 forming a stop against which the syringe contacts when inserted into the container 60. The boss 74 is arranged in the following manner: when the syringe 4 comes into contact with it, its cannula 7a has pierced the septum 6 of the filling reservoir 64 and penetrated into the filling reservoir.
Under these conditions, the syringe is filled with a defined dose of therapeutic product in the following manner. First, the plunger rod 11 of the syringe 4 is pushed such that its plunger 9 abuts against the bottom of the syringe, and then the cap 72 is rotated, which has the effect of pushing the plunger 70 and expelling a quantity of therapeutic product into the syringe 4 via the cannula 7a while pushing the plunger 9 of the syringe 4.
It will be appreciated that this filling method has the first advantage of avoiding cavitation between the plunger 9 of the syringe and the therapeutic product.
In addition, the amount of therapeutic product injected into the syringe 4 can be monitored by means of a means (means) for controlling the longitudinal displacement of the cap 72 with respect to the housing 3a, which means can be of the type used in the device as shown in fig. 9.
As shown in fig. 15, a longitudinal window 76 is preferably formed through the housing 3a so that the position of the syringe 4, and in particular its plunger 9, can be seen through said window. On the housing 3a, at the edge of the window 76, a scale 78 should also be made, spaced at a distance corresponding to the dose of product to be injected. Thus, the user of the syringe will screw on the cap 72 until the distal portion 9a of the plunger 9 of the syringe is opposite the scale 78 corresponding to the amount of therapeutic product he wishes to inject, i.e. 20 units in fig. 15 for example.
Once the desired dose has been loaded into the syringe, the user removes the syringe from the filling device 2 and can perform an injection. By inserting another syringe into the container 60 of the filling device 2 and doing so as described above, the user can easily start (the filling of) another syringe again.
Such a method of filling a syringe, in particular a standard syringe, and a filling device for performing the method is particularly advantageous in case the dose has to be repeatedly injected or adjusted daily, in particular in case the therapeutic product is e.g. insulin or growth hormone, because of the ease of use, making it suitable for the patient himself.
Furthermore, it has been demonstrated in testing that this arrangement provides a precision comparable to that provided by conventional pen injectors, and also facilitates injection of large volumes of therapeutic product, without being limited by the dose limits and injection time of the pen injector. This allows manual injection based on an injection device filled by means of a rotationally controlled member (unit), which can perform all the functions of a conventional pen injector using a simple standard injector and which can be smaller, simpler, lighter, stronger and thus cheaper.
It is known that for certain injectable products, it may be necessary to mix the two base products prior to injection, especially in the case of temporary preparations, such as for example in the case of reconstitution of certain compound formulations. It may also be necessary to transfer all or part of the therapeutic product from the primary package to a reservoir, which is then used for injection.
The most common method is to use two syringes, each containing one of the two products to be mixed, which are connected together by a connector. The product is then moved back and forth from one syringe to another, producing a homogenous mixture. All the mixed product is then transferred to one of two syringes, which are used as injection syringes.
It will be appreciated that while multiple transfers of the base product from one syringe to another syringe may be accomplished easily and quickly when the plunger rods of these syringes are pressure actuated, this is not the case when the plunger rods are actuated by rotation, such as in the devices described by way of example in fig. 8, 9, 11 and 14.
The present invention, as shown in fig. 16a, 16b and 16c, overcomes this disadvantage and can easily ensure that mixing is performed prior to injection of the two base products, while allowing injection by the rotational action of its plunger rod.
In this case, the injection device comprises a syringe 4, the proximal end of which is held between a circular flange 80 and a holding plate 82 fixed thereto by any means (not shown in the figures) and is penetrated by a threaded hole 84, the diameter of which is slightly larger than the diameter of the plunger rod 11 of the syringe. The proximal end of the plunger rod 11 terminates in a cylindrical pin 86 having a diameter smaller than the diameter of the plunger rod 11. Thus, in addition to the injector 4, the injection device comprises two control heads, namely a pressure control head 88 and a rotation control head 90.
The pressure control head 88 consists of a cylindrical rod 89 of smaller diameter than the threaded bore 84 and close to the diameter of the plunger rod 11, the distal end of which is hollowed out with an axial recess 92, which axial recess 92 allows it to receive the pin 86, the proximal end of which is formed by a flat 94, as shown in fig. 16 b. It will be appreciated that the injection device thus constituted can be used as a pressure-controlled syringe, which enables it to easily and quickly perform the aforementioned (product) transfer from syringe to syringe.
As in the previous embodiment shown in the above figures, the rotary control head 90 has a bell cap 96, the bottom of which bell cap 96 has an axial threaded portion 98 adapted to be screwed into the threaded bore 84 and is penetrated by an axial recess 100, the axial recess 100 being adapted to receive the pin 86, as shown in fig. 16 c. It will be appreciated that when formed in this manner, the injection device is capable of functioning like a rotation-controlled syringe, since rotation in the direction of screwing of the cap 96 has the effect of pushing the plunger rod 11, thus causing the injection of the therapeutic product contained in the syringe 4.
The advantage of this embodiment is that by simply changing the control head, the user can easily and quickly cause the product to be mixed back and forth between the syringes and the therapeutic product to be injected by the rotary controlled injection device.
It is well known that when intramuscular injection is performed using conventional injection devices, such as single or dual chamber syringes or cartridges, it is necessary to ensure that the administration is not intravenous. This is why once the needle is inserted, the doctor performs an examination by aspiration with the plunger of the syringe, called "venous examination". If blood returns, this means that blood flows back to the syringe and the doctor will confirm that the needle is in the vein and therefore he or she cannot perform the injection.
In injection devices in which the injection is not by pressure but by rotation, aspiration by withdrawing the plunger is more difficult to achieve, especially if the injected product is viscous or highly viscous.
However, the applicant has found that, for example in the case of a glass cartridge, when the crimp ring seals against the neck of the reservoir, the contact between the two parts (due to their metallic constitution on glass) prevents the passage of liquids or semi-solids, but is not completely air tight. In these cases, if the user inserts the needle into the blood vessel, blood pressure can cause blood to rise in the needle while air escapes through the reservoir-crimp ring junction. The blood then replaces the air in the reservoir, staining the distal portion visible to the physician. As with the standard injection device of the syringe type, the presence of blood in the reservoir indicates that an injection cannot be made at that particular location.
Under these conditions, it will be appreciated that the rotary injection mode according to the invention allows automatic intravenous examination.
A device commonly referred to as a "nest" for packaging syringes or cartridges is shown in fig. 17 and is commonly used for filling products in liquid form or low viscosity products.
According to the invention, the device is used to ensure the packaging of a series of syringes or cartridges intended to contain a first base product intended to be subsequently mixed with a second base product, in particular, for the immediate preparation of an injectable therapeutic product, the first base product being able to be present in particular in dry or freeze-dried form.
Thus, a packaging device is understood to be a "nest" which, in a known manner, comprises a tub 102, which is closed by a lid 104 and comprises means (or devices) capable of vertically holding a set of containers (desired to be filled or processed) made up of cartridges or syringes 4. The cover 104 is provided with a member for centering, which is composed of four male bolts 106 fixed at corners of the cover and below a lower surface of the cover, and can be received in four female bolts 108 arranged on the tub 102 to face the male bolts. The helical compression spring 110 surrounds the male and female bolts and ensures that the cover 104 remains in the open position when they are in the uncompressed position (fig. 17).
According to the invention, the lower surface of the cap 104 is provided, aligned with each syringe 4, with a projection 112 perpendicular to the surface of the cap, intended to frictionally receive a plunger intended to subsequently constitute the plunger 9 of the syringe 4.
The packaging method according to the present invention is performed as follows. First, the syringe is filled with any conventionally known means, and then an optional drying or freeze-drying operation is performed, wherein the spring 110 holds the cap 104 in place during this operation. At the end of the drying or freeze-drying operation, a pressure P is applied to the outer surface of the cap 104, against the force exerted by the spring 110, so as to insert each plunger 9 into the reservoir of the syringe 4 facing it. This operation may be performed in a chamber or freeze dryer maintained under a calculated air or inert gas vacuum. The vacuum may then be broken to return to ambient pressure so that the ambient pressure exerts a force on each plunger 9 which acts to retain the plunger in each reservoir when the pressure P applied to the cap 104 is stopped and each spring 110 lifts it. The product is then packaged (filled) in the syringe 4 and may be mixed with the liquid portion and then preferably injected using the device according to the invention as described above in fig. 16a, 16b and 16 c.
The invention also relates to a passive safety injection device intended to increase the stability of its positioning during injection and to protect its needle before, during and after injection.
Such safety devices are considered passive in that, on the one hand, their operation is completely independent of the way the user performs the injection, and, on the other hand, the user cannot perform operations or errors that would prevent their activation, such as incomplete injection before the needle is withdrawn.
A specific embodiment of such an injection device is shown in fig. 20 to 23 a.
The injection device 121 comprises a tubular body 123, which tubular body 123 is hollowed out with an axial cylindrical conduit 125, which axial cylindrical conduit 125 leads to a cylindrical distal chamber 127 of larger diameter. The tubing 125 houses a reservoir, which in this embodiment is constituted by a syringe 129 containing the product to be injected, which syringe 129 terminates in an injection needle 131. The distal end of the syringe 129 is provided with an O-ring seal 132, the O-ring seal 132 being inserted into the groove 130 of the body 123 and the length of the chamber 127αSo that in the rest or pre-injection position, as shown in fig. 1, the injection needle 131 is housed within the chamber 127.
The proximal end 123b of the body 123 terminates in two diametrically opposed hooked tabs 134 which themselves terminate in a heightHFollowed by a bevel 134b, which are deformable by the presence of an inner space 135.
The plunger 136 is slidably mounted within the syringe 129 by the action of a threaded plunger rod 137. The proximal end of the plunger rod is integral with the bottom of the actuation member consisting of a cylindrical cap 139 with an inner diameterDSlightly larger than the inner diameter of the body 123dThe height of the two stops 134a is added to allow the cover 139 to slide on the body. Thus, d=d+2xh. In the rest position (see fig. 1), the distal end of the cap 139 engages slightly on the body 123.
A first circular distal stop 146 having a rectangular cross-section height h is provided on the inner surface of the cap 139 to capture the body 123 in the cap 139 after the needle has been removed from the body 124 once the injection of product has ended. Finally, the inner surface of the cap has a second rounded proximal stop 145 of height h, the proximal face 145a of which is preferably inclined and the distal face 145b of which is radial, and spaced from the first stop 145 by a distance equal to the width of the boss 134a, and which, as described below, is intended to prevent the needle 131 from withdrawing again once the injection procedure is completed.
A cylindrical nut 141 of thickness e forming a stop is screwed onto the plunger rod 137 and comprises a groove 140, the proximal end of the syringe 129 being fixed in the groove 140. The periphery of the distal surface of the nut 141 is hollowed out with a circular recess 143 that is complementary in shape to the beveled corner 134b of the deformable tab 134. The diameter b of the nut 141 is slightly smaller than the inner diameter D of the cap 139, from which the height of the two bosses 134a is subtractedH. Thus, b=d-2 xH is obtained.
When the injection device is stationary, as shown in fig. 1, there is a distance between the proximal end 123b of the body 123 and the distal surface of the nut 141cThe distance the needle emerges from the distal surface 123a of the body 123 during injection can be controlled as described below.
The distal surface 123a of the cylindrical body 123 may be formed by an annular surface of the body 123, or as in the embodiment shown in fig. 2, may include an extension 123c so that the size of the surface may be increased.
The latter is coated with an adhesive that is capable of adhering to the skin 124 of the patient to be treated. For example, adhesive surfaces based on silicones, acrylates, polyacrylates or any other known copolymers in compositions for adhesive surfaces of medical devices such as dressings, ostomy bags, electrosurgical electrodes and plates, patches or capillary prostheses may be used. The adhesive face should be protected by a cover or film 147.
Under these conditions, the operation of the injection device according to the invention is as follows.
After removing the protective film 147, the user brings the adhesive distal end of the injection device into contact with the area of the patient's body where he or she wishes to perform an injection. This end of the injection device is then stabilised by its adhesion to the injection site.
The user then applies linear pressure on cap 139 in the direction of arrow F until nut 141 comes into contact with proximal surface 123b of body 123, which first causes injection needle 131 to be withdrawn from the injection device and introduced into the body of patient 124, as shown in fig. 3. On the other hand, at the end of the translational movement, the bevel 134b of the tab 134 penetrates into the groove 143 of the nut, as a result of which the tab 134 is deformed inwards and the nut 141 establishes a rotational connection with the body 123. In addition, due to the inward deformation of the tabs, when they reach the circular stops 145 and 146 during injection, they are free and cannot block the movement of the cap.
The injection device is now ready to inject the therapeutic product.
To this end, the user rotates cap 139, which can be done with one hand, because of the connection between distal portion 123a of body 123 and the body of patient 124, which is provided by the adhesive product. When cap 139 is rotated, valve stem 137 is threaded into nut 141, and when nut 141 is prevented from rotating relative to body 123, plunger 136 is moved into syringe 129 and delivers the therapeutic product into the patient until the plunger reaches the neck of syringe 129, or the user stops injection.
Once the injection is completed, the user pulls cap 139 in the direction opposite arrow F, with distal face 123a adhering to the patient's skin, pulling back on syringe 129 and nut 141, thereby releasing tab 134 and returning to its original position. Thus, the retraction movement is performed until the proximal surface of the boss 134a of the tab 134 comes into contact with the stop 145 and falls into the free space between the two stops 145 and 146, as shown in fig. 4 and 4 a.
This means that any relative movement of the cap 139 relative to the body 123 in the direction of arrow F or vice versa is no longer possible and the injection device is thus locked and secured against further use.
By continuing the retraction movement, the user ensures that the distal surface of the injection device is separated from the skin surface of the patient as the body 123 locks (snaps) against the second distal stop 146 relative to the cap 139.
It should be noted that the safety device equipped with the injection device has the advantage that the device is simpler, and therefore easier to implement and less costly, than current systems based on triggering, e.g. a spring mechanism.
Of course, while this example has been described for a small volume syringe such as an insulin type syringe, it is applicable to any other device using a standard or non-standard syringe or cartridge, and a screw injection mode may be employed, as described in this example, as well as a conventional translational injection mode using a conventional syringe with a smooth plunger rod and finger rest.
In this form of smooth plunger rod with translational actuation, cap 139 is replaced by two arms that are also integral with the plunger rod. The arms can pass through two windows inside the finger rest. As with the screw version, the needle is inserted by pushing the two arms in the direction of arrow F.
In addition, the safety device implemented in the present injection device has the advantage that the cap, which normally covers the injection needle, can be replaced. This eliminates the need to remove the cap, which is dangerous because it exposes the user to a sharp bevel, and also because it may damage the injection needle, finally because there is a risk of contamination of the outside of the needle prior to injection.
In an embodiment variant of the invention, the body 123 may comprise a window extending along the length of the syringe and enabling its content to be checked before use.
In addition, and in accordance with the present invention, the tag may attach the body 123 to the cap 139 in a manner that ensures the relative retention of the two portions prior to injection. Such a label would also make it possible to verify the integrity of the injection device seal prior to use. The label may include a predetermined cut line to facilitate its breakage during injection.

Claims (20)

1. Injection device comprising a cylindrical body (3) surrounding a reservoir (5) containing a product to be injected, said reservoir being open at one end of an injection needle (7) provided with a cannula (7 a) and closed at its other end by a plunger (9), said plunger (9) being mounted for translatable movement in said reservoir under the control of a plunger rod (11, 51) with control means (13, 13', 53), said injection device comprising a control unit for controlling the amount of product to be delivered, characterized in that said control unit is arranged on said body (3) in an area outside an area (16) intended to be completely gripped by hand of said body, said plunger rod (11) comprising a threaded portion (11 a) on which an adjustment wheel (15) is screwed, and said body (3) comprising two end stops, namely a distal stop (17 a) and a proximal stop (17 b), positioned between them, and said adjustment wheel (15) comprising a plurality of visible, and said proximal wheel (18) being able to be fitted with said at least one scale (18) of said adjustment wheels (3) in a peripheral area, thereby determining its longitudinal displacement relative to the threaded portion (11 a).
2. An injection device according to claim 1, characterized in that the area intended to be completely held by hand is located in a distal end area (16) of the injection device.
3. An injection device according to claim 1, wherein the region of the adjustment wheel (15) comprising the plurality of graduations (18) protrudes laterally from the body (3) in at least one region.
4. An injection device according to claim 1, wherein a proximal portion of the body (3) at least partially covers the adjustment wheel (15) and comprises at least one transparent area through which at least one of the plurality of graduations (18) is visible.
5. Injection device according to claim 1, wherein the proximal end portion of the body (3) forms a cylindrical housing (32) which is penetrated by a threaded portion (11 a) of the plunger rod (11), the adjustment wheel (15') being movable by screwing or unscrewing on the threaded portion (11 a) to reach the distal stop (17 a) from the proximal stop (17 b), which stops are formed by the two end walls of the housing (32), respectively.
6. An injection device according to claim 5, wherein the cylindrical housing (32) is open on one of its sides.
7. The injection device according to any of the preceding claims, wherein the reservoir (5) is constituted by a standard injection cartridge or syringe.
8. Injection device according to claim 1, wherein the plunger rod (11) comprises elements which frictionally act on the inner wall of the reservoir (5).
9. An injection device according to claim 8, wherein the element is an O-ring (22).
10. An injection device according to claim 1, wherein the distal portion of the body (3) comprises an extension element (28), the extension element (28) being penetrated by the cannula (7 a) of the injection needle (7), the cannula extending beyond the distal portion of the extension element (28) by a length (l) equal to the desired insertable length of the cannula.
11. The injection device according to claim 10, wherein the distal portion of the extension element (28) comprises a tapered portion (30).
12. An injection device according to claim 1, characterized in that it comprises an injection needle (7) provided with a cannula (7 a) hollowed out of the passage, the cannula (7 a) being fixed to a base (36) comprising an axially centred circular plate (36 a), the circular plate (36 a) of the needle base (36) resting against the distal face of the reservoir (5) by means of a connecting member.
13. Injection device according to claim 12, wherein the connecting member is a crimp member (39).
14. Injection device according to claim 12 or 13, wherein the reservoir (5) is a cartridge.
15. An injection device according to claim 12, wherein the connection between the base (36) and the distal face of the reservoir (5) is established in a non-sealing manner.
16. Injection device according to claim 1, wherein the reservoir (5) is closed by a membrane (6) using an injection needle (7) provided with a cannula (7 a) which excavates a channel, the cannula (7 a) being integral with a cylindrical base (37), characterized in that the length (m) of the rear portion (37) of the needle is slightly greater than the thickness of the membrane (6).
17. The injection device according to claim 1 or 2, wherein the body (3) comprises optionally removable means (47, 49) for holding the reservoir (4), the length of the body (3) being such as to allow exceeding the length (l, l ') of the cannula (7 a), said length (l, l') being equal to the length of the desired insertion.
18. Injection device according to claim 1, characterized in that it comprises an injection needle (7) provided with a cannula (7 a) hollowed out of the passage, the cannula (7 a) being fixed to a base (36) comprising an axially centred circular plate (36 a) having the same axis (xx') as an adjacent cylindrical boss (36 b) hollowed out of a cavity (36 c) communicating with the passage of the needle, the cavity (36 c) forming a converging duct from its proximal portion towards its distal portion.
19. Injection device according to claim 1, characterized in that it comprises an injection needle (7) provided with a cannula (7 a) hollowed out of the channel, the cannula (7 a) being integral with a cylindrical base (37), the cylindrical base (37) being formed by a tubular element comprising a channel (7 ") arranged in the extension of the channel of the cannula (7 a) and having an inner diameter (d 2) larger than the inner diameter (d 1) of the cannula (7 a).
20. An injection device according to claim 19, wherein the outer diameter of the base (37) is larger than the outer diameter of the sleeve (7 a).
CN201880078995.XA 2017-10-17 2018-10-16 Manual injection device Active CN111432863B (en)

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FR17/59714 2017-10-17
FR1759714A FR3072297B1 (en) 2017-10-17 2017-10-17 MANUAL INJECTION DEVICE
PCT/EP2018/078287 WO2019076921A1 (en) 2017-10-17 2018-10-16 Manual injection device

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US20200297936A1 (en) 2020-09-24
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EP4252802A2 (en) 2023-10-04
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WO2019076921A1 (en) 2019-04-25
KR102661861B1 (en) 2024-05-02
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JP2020537571A (en) 2020-12-24
KR20200104855A (en) 2020-09-04

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